510(k) K915650

HUMAN IGG SUBCLASS RID KIT by Janssen Biochimica — Product Code CGM

K915650 is an FDA 510(k) premarket notification submitted by Janssen Biochimica for the device "HUMAN IGG SUBCLASS RID KIT". The FDA issued a decision of Substantially Equivalent on March 26, 1992. The device falls under product code CGM (Method, Immunodiffusion, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510.